Role: Site Quality Head - Pharma
Salary: Highly Competitive
Russell Taylor Group has an excellent opportunity for a Quality Professional to lead and manage the strategic and operational performance of the Quality function, ensuring compliance to guidelines of products, processes, systems, and facility. This individual will control resource & cost budgets and ensure on time product delivery and that quality and compliance is met.
- Responsible for the strategy (quality) of the site
- Always assess Quality processes, systems, and the regulatory compliance status of products so that any compliance risks can be identified.
- Develop mitigations plans ensuring resourcing and that they are performed in a timely manner.
- Responsible for the Quality Compliance level of the site (local and global) to meet the regulatory authorities' guidelines, standards of the company and requirements of internal and external customers.
- Help maintain and improve the Site Quality operational performance (this will include quality, service, lead time and cost
- Make sure that the QMS is efficient and aligned with company standards and regulations. Periodically review this to identify any room for improvements, plans and further implementation
- Ensures efficient implementation of Deviation, Change Control, & CAPA. This will include ensuring the timely closure of PQRs and Customer complaints and driving process improvements
- Communicate any signification quality or regulatory issue or risks that may impact the product to the leadership team
- Responsible for the QC laboratory, ensuring a stability program is in place and that tests will be run on time
- Ensure all analytical methods for the lab are validation and match regulatory requirements
- Supports analytical method transfers and ensure that OOX results are thoroughly scrutinized
- Ensures timely batch disposition of products manufactured at the site and ones that are supplied and ensure that they are in line with the supply chain
- Prepares and manages Health Authority Inspections and Customers audits
- Will be a member of the site leadership team and Cluster Quality Leadership Team
- Develops the Site Quality team- which will involve planning, talent management and mentoring for development with annual goals for the team and individuals
- Ensure a strong training programme for GMP and SOP training
- Create the annual budget for the quality management organisation
- 10+ years' experience in the pharmaceutical industry (manufacturing, QA or QC)
- Qualified QP would be ideal
- BSc in pharmaceutical sciences or related field
- Previous experience in a "Head of" or quality director-based role
- Strong leadership skills- able to create a strong quality leadership team and manage, but also a team player
- Excellent at cost budgeting- previous experience would be ideal